Volcano Corporation announced the commercial release as well as the initial implantations of the novel device – Crux Vena Cava Filter (VCF). The commercial availability of this device is expected to reduce life-risk of patients afflicted by recurrent pulmonary embolism (PE).
Pulmonary embolism is a condition characterized by blockage of the main artery of the lung or one of its branches by a substance which usually migrates from a different part of the body through the bloodstream (embolism). The condition affects about 600,000 patients, resulting in 200,000 deaths annually in the United States.
Between Jun 2010 and Jun 2011, the Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System trial had been conducted to evaluate the effectiveness and safety of the device. The single-arm clinical trial covering 125 patients, achieved an encouraging clinical success rate of 96%. Moreover, the problem of filter tilt was also overcome successfully. Eventually, the Crux VCF System received the CE Mark in Dec 2011 and 510(k) clearance in Jul 2012.
The successful outcomes associated with the device prompted Volcano to take over Crux Biomedical, a privately-held company that came up with a highly differentiated inferior vena cava (IVC) filter—the Crux VCF System—to treat pulmonary embolisms (PE).
The IVC filter market in the U.S. is estimated to be worth $300 million, and the acquisition of the innovative device can be a major revenue driver in Volcano’s core business. Currently, North America has the highest demand, followed by Europe.
The acquisition complements Volcano’s growth strategy to enter the peripheral market and diversify beyond coronary applications. On the other hand, Crux believes that the partnership with Volcano will ensure widespread adoption of the state-of-the-art Crux VCF, in the peripheral market.
Vena cava filter is a medical device which acts as a barrier for blood clots moving to the lungs. Filters that are integrated in the inferior vena cava (IVC) are meant to considerably reduce repetitive PE occurrences in patients. It is an alternative therapy for patients who are advised against conventional medical procedures or fail to respond to available therapies.
On a larger scale, the Crux VCF is a cutting-edge therapy that has been meticulously designed to facilitate smooth retrieval of the filter, either through the femoral or jugular vein. Prolonged filter retention can lead to filter fracture, filter migration, filter embolization and IVC perforation.
Additionally, it provides filtration across the entire lumen of the vessel. It is the only filter with a double helical design that self-centers to help prevent filter tilt, which often hampers the device retrieval process.
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